Participants get first access to game-changing platform for low frequency allele detection using their own samples. RainDance Technologies, Inc., the Digital Biology™ Company, today announced that it has begun accepting biological samples from participants of the RainDrop™ Digital PCR First Access Program.

Institutions and researchers accepted into this program are being given first access to run their samples against their own assays, or several ready-made assays, on the RainDrop system, as well as shipment and installation priority on system purchases made before commercial deliveries begin later this year.

Built on RainDance’s patented and proven RainStorm™ picodroplet technology, the RainDrop System generates up to 10 million picoliter-sized droplets per sample which is 500x - 1,000x more data points than legacy digital PCR offerings. Since each droplet encapsulates a single molecule, researchers can quickly determine the absolute number of droplets containing specific target DNA and compare that to the number of droplets with non-target DNA. The RainDrop System also shifts the current digital PCR paradigm from a single-color-per-marker approach to a two-color and varying probe intensity method that is capable of multiplexing up to 10 markers.

Initial applications for digital PCR include low frequency allele detection (e.g., blood screening of cell-free circulating DNA or RNA), copy number variation and gene expression studies. “Our RainDrop System represents a fundamental breakthrough in PCR and the third generation of instruments built on our proven picodroplet technology,” said Rena McClory, Marketing Director, Digital PCR Business at RainDance Technologies. “We have already received purchase orders from customers in the U.S. and Europe and are very pleased with the significant interest we’ve seen to-date. We look forward to welcoming additional researchers into our First Access Program and are confident they will be very pleased with the data that is generated and its potential contribution to their research and publications.”

In a recent Lab on a Chip paper, scientists from Université de Strasbourg and Université Paris Descartes used the RainDance dPCR technology to detect a single mutated copy of KRAS in a background of 200,000 wild-type copies. By processing reactions in millions of picoliter droplets, the platform improved sensitivity over 100x compared to existing technologies.

“The combination of superior sensitivity, unprecedented multiplexing, and flexibility in experiment design provides a powerful genomic analysis platform for new research in cancer including rare variant detection, absolute quantitation of biomarkers, tumor profiling, and the ability to monitor residual disease,” said Darren Link, Ph.D., co-founder and Vice President of Research and Development at RainDance Technologies. “We already have 10 ready-to-go, high-performing assays covering mutations in several oncogenes including the T790M and L858R mutations in EGFR which can be quantitated at a mutant-to-wild type ratio of better than 1:6,000 and 1:100,000, respectively. We have also been successful in converting qPCR assays into digital PCR assays with performance of 100x-1,000x better sensitivity."